Subcutaneous Treatment In Randomized Subjects To Evaluate Safety And Efficacy In Generalized Lupus Erythematosus

Lupus Erythematosus, Systemic Clinical Trial

— BUTTERFLY  

Official title:

A Double-blind, Randomized, Placebo-controlled, Multicenter Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-04236921 In Subjects With Systemic Lupus Erythematosus (Sle)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01405196
• Other study ID #: B0151006
• Secondary ID: 2011-000420-15BU
• Status: Completed
• Phase: Phase 2
• First received: July 27, 2011
• Last updated: December 18, 2017
• Start date: December 2011
• Est. completion date: March 2014

Study information

• Verified date: December 2017
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate and compare efficacy of 3 dose levels of PF-04236921 to placebo in subjects with generalized lupus using a measure called the Systemic Lupus Erythematosus (SLE) Responder Index. The study will evaluate secondary and exploratory measures as well.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Male or female subjects between ages of 18 and 75 years old at time of signing consent.

• Have a clinical diagnosis of SLE according to 1997 update on the revised 1982 American College of Rheumatology (ACR) criteria.

• Have a unequivocally positive anti-nuclear antibody (ANA) test result.

• Active disease at screening defined by both: SLEDAI-2K score greater than or equal to 6 and BILAG Level A disease in more than or equal to 1 organ system (except renal or central nervous system) or BILAG B disease in more than or equal to 2 organ systems if no level A disease in present.

Exclusion Criteria:

• Any prior history of treatment with PF-04236921, or anti-IL-6 agent;

• Have received any of the following within 364 days of day 1: a biologic investigational agent other than B cell targeted therapy; required 3 or more courses of systemic corticosteroids for concomitant conditions; history of previously untreated or current evidence of active or untreated latent infection with Tuberculosis (TB), evidence of prior untreated or currently active TB by chest radiography, residing with or frequent close contact with an individual with active TB.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic

Intervention

Biological:
• PF-04236921
subcutaneous injection; administered at day 1, weeks 8, 16.
• PF-04236921
subcutaneous injection; administered at day 1, weeks 8, 16.
• PF-04236921
subcutaneous injection; administered at day 1, weeks 8, 16.
• PF-04236921
subcutaneous injection; administered at day 1, weeks 8, 16

Locations

Country	Name	City	State
Argentina	Centro de Educación Medica e Investigaciones Clinicas "Norberto Quirno" CEMIC	C.a.b.a
Argentina	Framingham Centro Medico	La Plata	Buenos Aires
Argentina	Instituto CAICI S.R.L.	Rosario	Santa FE
Argentina	Centro Polivalente de Asistencia e Investigación Clínica - CER- San Juan	San Juan
Argentina	Centro Medico Privado de Reumatologia	San Miguel de Tucuman	Tucuman
Chile	Centro de Estudios Reumatologicos	Santiago	RM
Chile	Centro Medico Prosalud	Santiago	RM
Chile	Sociedad Medica del Aparato Locomotor S.A. (SOMEAL)	Santiago	Region Metropolitana
Colombia	Centro Integral de Reumatología del Caribe CIRCARIBE SAS	Barranquilla	Atlantico
Colombia	Congregacion de Hermanas Franciscanas Misioneras de Maria Auxiliadora- Clinica Asunción	Barranquilla	Atlantico
Colombia	Organizacion Clinica General del Norte S.A.	Barranquilla	Atlantico
Colombia	Centro Integral de Reumatologia e Inmunologia S.A.S.- CIREI S.A.S.	Bogota	Cundinamarca
Colombia	Farmamix Ltda.	Bogota
Colombia	Riesgo De Fractura S.A	Bogota	Cundinamarca
Colombia	Farmamix Ltda.	Bogota, Distrito Capital	Cundimarca
Colombia	Servimed E.U	Bucaramanga	Santander
Colombia	Centro Integral de Reumatologia REUMALAB S.A.S.	Envigado	Antioquia
Colombia	Mix Supplier S.A.	Envigado	Antioquia, Colombia
Colombia	Hospital Pablo Tobon Uribe	Medellin	Antioquia
Germany	Charité - Universitaetsmedizin Berlin	Berlin
Germany	Charité University Medicine Berlin. Schlosspark-Klinik	Berlin
Germany	Universitaetsklinikum Erlangen	Erlangen
Germany	CIRI am Klinikum der Goethe-Universitaet	Frankfurt/Main
Germany	Universitaetsklinikum Koeln	Koeln
Germany	Universitaetsklinikum Leipzig AoeR, Department fuer Innere Medizin	Leipzig
Hungary	Qualiclinic Kft.	Budapest
Hungary	Debreceni Egyetem Orvos és Egeszsegtudomanyi Centrum	Debrecen
Hungary	Bekes Megyei Kepviselo-testulet Pandy Kalman Korhaz Infektologia, Hepatologia es Immunologia	Gyula
Korea, Republic of	Dong-A University Medical Center 1	Busan
Moldova, Republic of	Spitalul Clinic Republican	Chisinau	Md-2025
Peru	Unidad de Investigación en Medicina Interna y Enfermedades Críticas	Arequipa
Peru	Centro de Investigacion REUMED, Clinica Anglo Americana	San Isidro	Lima
Peru	Investigaciones Clínicas SAC	Santiago de Surco	Lima
Peru	Investigaciones Clinicas SAC	Surco	Lima
Poland	NZOZ Centrum Reumatologiczne Indywidualna Specjalistyczna Praktyka Lekarska lek.med. Barbara Bazela	Elblag
Poland	Medyczne Centrum Hetmanska - Indywidualna Specjalistyczna Praktyka Lekarska -	Poznan
Poland	Prywatna Praktyka Lekarska Prof. UM Dr hab. med. Pawel Hrycaj	Poznan
Poland	Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych	Warszawa
Puerto Rico	University of Puerto Rico	Rio Piedras
Puerto Rico	Division of Rheumatology, Allergy and Immunology	San Juan
Romania	Spitalul Clinic Colentina	Bucuresti
Romania	Spitalul Clinic Sf. Maria	Bucuresti
Romania	Spitalul Clinic Jedetean de urgenta Cluj, Reumatologie	Cluj Napoca
Romania	Spitalul Clinic Judetean de Urgenta "Sf. Apostol Andrei"	Galati
Taiwan	National Taiwan University Hospital	Taipei TOC
United States	Albuquerque Clinical Trials	Albuquerque	New Mexico
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	University of Michigan Health System,	Ann Arbor	Michigan
United States	Anniston Medical Clinic, PC	Anniston	Alabama
United States	Pinnacle Research Group, LLC	Anniston	Alabama
United States	Emory University	Atlanta	Georgia
United States	Grady Health Systems	Atlanta	Georgia
United States	Johns Hopkins Outpatient Center	Baltimore	Maryland
United States	Johns Hopkins Outpatient Express Testing Center	Baltimore	Maryland
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland
United States	Achieve Clinical Research, LLC	Birmingham	Alabama
United States	Tufts Medical Center/ Center for Arthritis and Rheumatic Diseases	Boston	Massachusetts
United States	Arthritis and Osteoporosis Medical Associates, PLLC	Brooklyn	New York
United States	The University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	The University of North Carolina Clinical and Translational Research Center	Chapel Hill	North Carolina
United States	The University of North Carolina Hospitals Investigational Drug Services	Chapel Hill	North Carolina
United States	Low Country Rheumatology, PA/Low Country Research	Charleston	South Carolina
United States	Box Arthritis & Rheumatology of the Carolinas, PLLC	Charlotte	North Carolina
United States	Joint and Muscle Medical Care	Charlotte	North Carolina
United States	University of Chicago Medical Center	Chicago	Illinois
United States	Mountain State Clinical Research	Clarksburg	West Virginia
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	UT Southwestern Medical Center	Dallas	Texas
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Asthma, Allergy, Arthritis and Lung Center	Daytona Beach	Florida
United States	Henry Ford Health System (Henry Ford Medical Center)	Detroit	Michigan
United States	Med Investigations, Inc.	Fair Oaks	California
United States	Southeastern Arthritis Center	Gainesville	Florida
United States	Southeastern Community Pharmacy	Gainesville	Florida
United States	Southeastern Integrated Medical, PL, d/b/a Florida Medical Research Institute	Gainesville	Florida
United States	Southeastern lmaging & Diagnostics	Gainesville	Florida
United States	Beacon Medical Group Rheumatology	Granger	Indiana
United States	Accurate Clinical Research, Inc.	Houston	Texas
United States	Rheumatic Disease Clinical Research Center, LLC	Houston	Texas
United States	Indiana CTSI Clinical Research Center	Indianapolis	Indiana
United States	Investigational Drug Services	Indianapolis	Indiana
United States	Arthritis Clinic	Jackson	Tennessee
United States	West Tennessee Research Institute	Jackson	Tennessee
United States	Premier Clinical Research, LLC	Lakewood	California
United States	University of Nevada School of Medicine	Las Vegas	Nevada
United States	Novo Research	Long Beach	California
United States	St Mary Medical Center	Long Beach	California
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Ronald Reagan UCLA Medical Center	Los Angeles	California
United States	UCLA Division of Rheumatology	Los Angeles	California
United States	UCLA Medical Center	Los Angeles	California
United States	UCLA Rheumatology Clinical Research Center	Los Angeles	California
United States	Wallace Rheumatic Study Center	Los Angeles	California
United States	Feinstein Institute for Medical Research	Manhasset	New York
United States	Idaho Arthritis Center	Meridian	Idaho
United States	Southwest Rheumatology Research, LLC	Mesquite	Texas
United States	New Horizon Research Center	Miami	Florida
United States	Paramount Medical Research and Consulting, LLC	Middleburg Heights	Ohio
United States	NYU Center for Musculoskeletal Care	New York	New York
United States	Oklahoma Medical Research Foundation	Oklahoma City	Oklahoma
United States	Arthritis Associates	Orlando	Florida
United States	Millennium Research	Ormond Beach	Florida
United States	The Arthritis Center	Palm Harbor	Florida
United States	Advent Clinical Research Centers, Inc.	Pinellas Park	Florida
United States	Allergy/Immunology and Rheumatology	Rochester	New York
United States	Shores Rheumatology P.C	Saint Clair Shores	Michigan
United States	The Seattle Arthritis Clinic	Seattle	Washington
United States	Tacoma Center for Arthritis Research, PS	Tacoma	Washington
United States	Burnette & Silverfield, MDS PLC	Tampa	Florida
United States	Inland Rheumatology and Osteoporosis Medical Group	Upland	California
United States	Inland Rheumatology Clinical Trials, Inc.	Upland	California
United States	Clinical Research Center of Reading, LLP	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Chile,  Colombia,  Germany,  Hungary,  Korea, Republic of,  Moldova, Republic of,  Peru,  Poland,  Puerto Rico,  Romania,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 24	SRI components include:Systemic Lupus Erythematosus Disease Activity Index 2000(SLEDAI-2K),British Isles Lupus Assessment Group(BILAG) 2004,Physician's Global Assessment(PhGA).Participants classified as responder if they did not meet definition of treatment failure and met all the following criteria: greater than or equal to(>=) 4 point reduction in SLEDAI-2K score; no new BILAG A organ domain score or 2 new BILAG B organ domain scores; no worsening (less than [<] 0.3 point increase) in PhGA score. Treatment failure: any new/increased use of corticosteroids,immunosuppressants/antimalarial drug, any death, hospitalization/treatment discontinuation due to SLE, any flare of lupus interfering with participation in study. SLEDAI-2K:assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). BILAG:assesses disease extent, severity (range: A[severe] to E[no disease]). PhGA: assesses worsening in participant's general health status(range: 0[none] to 3[severe]).	Week 24
Secondary	Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 4, 8, 12, 16, and 20	SRI components include:SLEDAI-2K ,BILAG 2004, PhGA. Participants classified as responder if they did not meet definition of treatment failure and met all the following criteria: >=4 point reduction in SLEDAI-2K score; no new BILAG A organ domain score or 2 new BILAG B organ domain scores; no worsening (<0.3 point increase) in PhGA score. Treatment failure: any new/increased use of corticosteroids,immunosuppressants/antimalarial drug, any death, hospitalization/treatment discontinuation due to SLE, any flare of lupus interfering with participation in study. SLEDAI-2K: assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). BILAG:assesses disease extent, severity (range: A [severe] to E [no disease]). PhGA: assesses worsening in participant's general health status(range: 0[none] to 3[severe]).	Week 4, 8, 12, 16, 20
Secondary	Percentage of Participants Achieving Modified Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 4, 8, 12, 16, 20, and 24	SRI components include: modified SLEDAI-2K (SLEDAI-2K without standard parameters "Low complement" and "Leukopenia"), BILAG 2004, PhGA. Participants classified as responder if they did not meet definition of treatment failure and met all the following criteria: >=4 point reduction in SLEDAI-2K score; no new BILAG A organ domain score or 2 new BILAG B organ domain scores; no worsening (<0.3 point increase) in PhGA score. Treatment failure: any new/increased use of corticosteroids, immunosuppressants/antimalarial drug, any death, hospitalization/treatment discontinuation due to SLE, any flare of lupus interfering with participation in study. Modified SLEDAI-2K: assesses improvement in disease activity (range: 0 to 102; higher score = higher severity). BILAG: assesses disease extent, severity (range: A [severe] to E [no disease]). PhGA: assesses worsening in participant's general health status (range: 0[none] to 3[severe]).	Week 4, 8, 12, 16, 20, 24
Secondary	Percentage of Participants Achieving British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) Response at Week 4, 8, 12, 16, 20, and 24	BICLA include: BILAG-2004, SLEDAI-2K, PhGA of disease activity. Participants classified as responder if they did not meet the definition of treatment failure and met all the following criteria: BILAG-2004 improvement (all A scores at baseline improved to B/C/D and all B scores improved to C or D); no worsening in disease activity (no new BILAG-2004 A scores or =<1 new B score); no worsening of total SLEDAI-2K score; no significant deterioration (<10 percent [%] worsening) in analogue PhGA. Treatment failure: any new/increased use of corticosteroids,immunosuppressants/antimalarial, any death, hospitalization/treatment discontinuation due to SLE, any flare of lupus interfering with participation in study. BILAG:assesses disease extent, severity (range: A[severe] to E[no disease]). SLEDAI-2K:assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). PhGA: assesses worsening in participant's general health status(range: 0[none] to 3[severe]).	Week 4, 8, 12, 16, 20, 24
Secondary	Percentage of Participants Achieving Pre-defined Criteria for Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Components at Week 24	SRI components include: SLEDAI-2K, BILAG 2004 and PhGA. Participants classified as responder if they did not meet definition of treatment failure and met all the following criteria: >=4 point reduction in SLEDAI-2K score; no new BILAG A organ domain score or 2 new BILAG B organ domain scores; no worsening(<0.3 point increase) in PhGA score. Treatment failure: any new/increased use of corticosteroids, immunosuppressants/antimalarial drug, any death, hospitalization/treatment discontinuation due to SLE, any flare of lupus interfering with participation in study. SLEDAI-2K: assesses improvement in disease activity(range: 0 to 105; higher score = higher severity). BILAG: assesses disease extent, severity (range: A[severe] to E [no disease]). PhGA: assesses worsening in participant's general health status (range: 0[none] to 3[severe]). Model percent estimates reported only for 'Reduction in SLEDAI Score','No Worsening in PhGA' categories; for remaining categories, raw percentages reported	Week 24
Secondary	Number of Participants With Clinically Significant Laboratory Tests Results	Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance. Laboratory values included Alanine Aminotransferase (ALT) [>5.0 - 10.0*Upper limit of normal range (ULN)], Albumin [<26-20 gram per liter (g/L)/ <20 g/L], Amylase [>2.0 - 5.0*ULN], Aspartate Aminotransferase (AST) [>5.0 - 10.0*ULN], Creatine Kinase (CK) [>5.0 - 10.0* ULN/ >10.0*ULN], Glucose (Hyperglycemia) [>13.9 - 27.8 millimoles/liter (mmol/L)], Hemoglobin (HGB) [<80 - 65 g/L/ <65 g/L], Lipase [>2.0 - 5.0*ULN], Lymphocytes (Lymph.)(Absolute [Abs]) [<0.5 - 0.2*10^3/microliter (UL)/ <0.2*10^3/UL], Platelets [<50-25*10^3/UL/ <25*10^3/UL], potassium (low) [<3.0 - 2.5 mmol/L], Sodium (low) [<130 - 120 mmol/L], Total Neutrophils (TN) (Abs) [<1.0 - 0.5*10^3/UL/ <0.5*10^3/UL], Triglycerides [>5.7 - 11.4 mmol/L], White Blood Cell Count (WBC) [<2.0 - 1.0*10^3/UL/ <1.0*10^3/UL].	Baseline up to Week 52
Secondary	Number of Participants Who Discontinued Due to Adverse Events	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants who discontinued due to adverse events were reported.	Baseline up to Week 52
Secondary	Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 52 that were absent before treatment or that worsened relative to pretreatment state. Number of participants with treatment-emergent AEs or SAEs (excluding infectious AEs or SAEs and injection site reactions) were reported. AEs include both SAEs and non-SAEs.	Baseline up to Week 52
Secondary	Number of Participants With Treatment-Emergent Infectious Adverse Events (AEs) or Serious Adverse Events (SAEs)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 52 that were absent before treatment or that worsened relative to pretreatment state. Number of participants with treatment-emergent infectious AEs or SAEs were reported. AEs include both SAEs and non-SAEs.	Baseline up to Week 52
Secondary	Number of Participants With Potentially Clinically Important (PCI) Electrocardiogram (ECG) Findings	Criteria for potentially clinically important (PCI) findings in ECG were defined as: heart rate <=40 beats per minute (bpm) or >=120 bpm; PR interval >=220 millisecond (msec); QT interval >=480 msec; QRS interval >=120 msec; QT interval corrected using the Fridericia formula (QTcF) >=500msec; no sinus rhythm.	Baseline up to Week 52
Secondary	Number of Participants With Potentially Clinically Important Vital Signs Findings	Criteria for PCI findings in vital signs were defined as: sitting systolic blood pressure (Increase from baseline >=20 millimeter of mercury (mm Hg) and >=160 mm Hg or a decrease from baseline >=20 mm Hg and <=90 mm Hg) and sitting diastolic blood pressure (increase from baseline >=15 mm Hg and >=90 mm Hg or decrease from baseline >=15 mm Hg and <=60 mm Hg), pulse rate (increase from baseline >=15 beats/min and >=120 beats/min or decrease from baseline >=15 beats/min and <=50 beats /min), body temperature (increase of >=2 degree Fahrenheit (F) and temperature >=101 degree F) and weight (change of >=7% in body weight)	Baseline up to Week 52
Secondary	Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (Nabs)	Human serum samples were analyzed for the presence or absence of anti-PF-04236921 antibodies. A positive ADA sample was further tested for neutralizing antibodies using a validated assay.	Baseline up to Week 52
Secondary	Serum Concentration of PF-04236921	Serum PF-04236921 concentrations over time were summarized.	Day 1, Week 2, 4, 6, 8, 12, 16, 20, 24
Secondary	Percentage of Participants With Corticosteroid Dose Reduced by Both Greater Than or Equal to (>=) 25 Percent (%) From Baseline and Less Than or Equal to (<=) 7.5 Milligrams Per Day (mg/Day)	Participants were given supplemental corticosteroids at baseline to control disease activity, if necessary. The steroid taper was based on participant's symptoms. Participants recorded their steroid usage on a diary card. Least Observation Carried Forward (LOCF) method was used to impute missing data.	Week 12, 16, 20, 24
Secondary	Percentage of Participants With Normalized Serological Activity	Serologic activity was to be assessed in the subgroup of participants who had positive serologic activity at baseline.	Baseline up to Week 24
Secondary	Patient Global Visual Analog Scale (VAS) Scores at Baseline	Participants assessed their disease activity using a 100 millimeter (mm) VAS. Participants answered the following question "Considering all the ways your disease affects you, how are you feeling today?" Response was recorded by placing a mark on the scale between 0 (very well) and 100 (extremely bad).	Baseline
Secondary	Change From Baseline in Patient Global Visual Analog Scale (VAS) at Week 2, 4, 6, 8, 12, 16, 20 and 24	Participants assessed their disease activity using a 100 mm VAS. Participants answered the following question "Considering all the ways your disease affects you, how are you feeling today?" Response was recorded by placing a mark on the scale between 0 (very well) and 100 (extremely bad).	Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24
Secondary	Change From Baseline in European Quality of Life 5 Dimensions Questionnaire (EQ-5D) at Week 4, 8, 12, 16, 20 and 24	EQ-5D is a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point VAS (0= worst imaginable health state, 100= best imaginable health state).	Baseline, Week 4, 8, 12, 16, 20, 24
Secondary	Thirty Six-Item Short-Form Health Survey (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) at Baseline	SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as PCS and mental component score MCS. The score for each aspect and PCS/MCS is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). LOCF method was used to impute missing values.	Baseline
Secondary	Change From Baseline in 36-Item Short-Form Health Survey (SF-36) PCS and MCS at Week 4, 8, 12, 16, 20 and 24	SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical component score (PCS) and mental component score (MCS). The score for each aspect and PCS/MCS is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). LOCF method was used to impute missing values.	Baseline, Week 4, 8, 12, 16, 20, 24
Secondary	Change From Baseline in Vitality Scores at Week 4, 8, 12, 16, 20 and 24	SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. Vitality sub-score is a component of SF-36 Health Survey Questionnaire and assesses energy and fatigue. The vitality score ranged from 0-100 (100=highest level of functioning). LOCF method was used to impute missing values.	Baseline, Week 4, 8, 12, 16, 20, 24
Secondary	Change From Baseline in Short Form-6 Dimension (SF-6D) at Week 4, 8, 12, 16, 20 and 24	The SF-6D focuses on seven of the eight health domains covered by the SF-36 Health Survey: physical functioning, role participation (combined role-physical and role-emotional), social functioning, bodily pain, mental health, and vitality. The SF-6D is an attempt to derive a single index from the SF-36 Health Survey for use in economic evaluation studies. As such, it represents a summary score based on a subset of the SF-36 data. Consequently, in lieu of the SF-6D, PCS and MCS SF-36 results are being provided. The score for each aspect and PCS/MCS is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). LOCF method was used to impute missing values.	Baseline, Week 4, 8, 12, 16, 20, 24
Secondary	Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Baseline	FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).	Baseline
Secondary	Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Week 4, 8, 12, 16, 20 and 24	FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). LOCF method was used to impute missing values.	Baseline, Week 4, 8, 12, 16, 20, 24

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